MAUDE Adverse Event Report: BAUSCH + LOMB CRYSTALENS ACCOMMODATING IOL; LENS, INTRAOCULAR, ACCOMMODATIVE

Model Number	AT52AO
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/25/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation of this event is in progress.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that patient was dissatisfied with vision due to z-syndrome.Reportedly, the patient noted decrease in his vision.The lens was explanted and replaced with a different model lens.The patient's current status is "good".
Additional Manufacturer Narrative
The lens was returned to b+l.Visual inspection found the lens cut in four pieces, portion of both haptics damaged (missing) and portion of both plates damaged (missing).Due to the condition in which the lens was returned further testing could not be performed.One retain sample from the same lot (7442205) was inspected and all measurements were found to be within specifications.The device history records were reviewed and there were no discrepancies or unusual finding that relate to the reported issue.Based on the information available, the root cause of the reported event could not be determined.
Event or Problem Description
Additional information: the patient's decrease in vision was described as "slow".Treatments administered for lens vaulting were implant of a capsular tension ring (ctr), yag, and lens was subsequently explanted.

• Brand Name: CRYSTALENS ACCOMMODATING IOL
• Common Device Name: LENS, INTRAOCULAR, ACCOMMODATIVE
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 5572670
• Report Number: 0001313525-2016-00143
• Device Sequence Number: 1059975
• Product Code: NAA
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AT52AO
• Device Lot Number: 74422405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2016
• Supplement Report FDA Received Date: 05/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other